A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA

Summary

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit

Conditions

• Asymptomatic Hyperuricemia

Interventions

DRUG

Verinurad

Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

DRUG

Febuxostat

Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

DRUG

Dapagliflozin

Randomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

OTHER

Dapagliflozin matched placebo

Randomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

Sponsors & Collaborators

• Contract Research Organization: USA

  collaborator UNKNOWN

• PAREXEL Early Phase Clinical Unit Baltimore

  collaborator UNKNOWN

• PAREXEL Early Phase Clinical Unit-Los Angeles

  collaborator UNKNOWN

• Clinical Laboratory: USA

  collaborator UNKNOWN

• Harbor Hospital Laboratory

  collaborator UNKNOWN

• GenX Laboratories Inc.

  collaborator UNKNOWN

• Analytical Laboratory (Pharmacokinetic Sample Analysis): USA

  collaborator UNKNOWN

• Covance Bioanalytical Services, LLC

  collaborator UNKNOWN

• AstraZeneca

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-25

Primary Completion

2018-07-19

Completion

2018-07-19

FDA Drug

Yes

Countries

• United States

Study Locations